Targeting Peroxisome Proliferator-Activated Receptor-Gamma in Peritoneal Dialysis Patients - Will it Reduce Inflammation, Atherosclerosis, Calcification and Improve Survival of Peritoneal Dialysis Patients? - Full Text View

Sponsored by:	Hospital Authority, Hong Kong
Information provided by:	Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:	NCT00516880

Purpose

Peritoneal dialysis patients are at increased risk of cardiovascular morbidity and mortality and are related to the presence of accelerated atherosclerosis. Our recent data showed that inflammation predicts mortality and cardiovascular death, independent of other cardiovascular risk factors in peritoneal dialysis patients. As a considerable proportion of peritoneal dialysis patients showed evidence of inflammation, it raises an important question as to whether anti-inflammatory treatment has any cardiovascular and survival benefit in these patients. The peroxisome proliferator-activated receptor-gamma (PPAR-g) agonist is a class of drug with insulin sensitizing property. Recent experimental and clinical studies demonstrated that this class of drug has anti-inflammatory and anti-atherosclerotic properties other than insulin sensitizing effect in type 2 diabetics. We therefore hypothesize that modulation of the PPAR-g activity may be a novel therapeutic strategy for reducing inflammation and retarding the progression of atherosclerosis and possibly lowering mortality in our peritoneal dialysis patients.

Condition	Intervention
Chronic Disease Kidney Diseases Cardiovascular Diseases	Drug: rosiglitazone

MedlinePlus related topics: Coping with Chronic Illness Kidney Failure

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Targeting Peroxisome Proliferator-Activated Receptor-Gamma in Peritoneal Dialysis Patients - Will it Reduce Inflammation, Atherosclerosis, Calcification and Improve Survival of Peritoneal Dialysis Patients?

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:

carotid athersclerosis [ Time Frame: 6 month, 1 year and 2 year ]
endothelial function [ Time Frame: 6 month, 1 year and 2 year ]

Secondary Outcome Measures:

all-cause mortality and cardiovascular event [ Time Frame: 1 year, 2 year ]
pulse wave velocity [ Time Frame: 6 month, 1 year, 2 year ]
inflammation [ Time Frame: 6 month, 1 year, 2 year ]

Estimated Enrollment:	160
Study Start Date:	March 2006
Estimated Study Completion Date:	November 2008

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Both prevalent patients or patients newly started on continuous ambulatory peritoneal dialysis with age between 20 - 75 with or without diabetes mellitus will be considered eligible for study entry. For patients newly started on continuous ambulatory peritoneal dialysis, they will be suitable for recruitment into the study after one month on continuous ambulatory peritoneal dialysis.

Exclusion Criteria:

Patients with underlying malignancy
Patients with chronic liver disease or liver cirrhosis
Patients with hepatitis B or C positive
Patients with active infections
Patients with other chronic active inflammatory disease such as systemic lupus erythematosus, rheumatoid arthritis
Patients who refuse study participation
Patients with underlying congenital heart disease or rheumatic heart disease
Patients with poor general condition
Patients with plans for living related kidney transplant within 2 years
Female patients with pregnancy
Patients with history of recurrent hypoglycemia
Patients with Class III and IV congestive heart failure
Patients already receiving glitazones treatment at the screening visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516880

Contacts

Contact: Angela Wang, Dr

(852) 2855 4949

aw2000_hk@yahoo.com

Locations

China
Department of Medicine, Queen Mary Hospital	Recruiting
Hong Kong, China
Sub-Investigator: KN Lai, Prof
Department of Medicine, Tung Wah Hospital	Recruiting
Hong Kong, China
Sub-Investigator: WK Lo, Dr

Sponsors and Collaborators

Hospital Authority, Hong Kong

Investigators

Principal Investigator:

Angela Wang, Dr

Department of Medicine/Nephrology, Queen Mary Hospital/ The University of Hong Kong

More Information

HAREC Clinical Trial Registry This link exits the ClinicalTrials.gov site

Study ID Numbers:	UW05-236T/899, HARECCTR0500007
Study First Received:	August 15, 2007
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00516880
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:

chronic kidney disease
cardiovascular disease

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Urologic Diseases
Renal Insufficiency, Chronic
Vascular Diseases
Kidney Failure, Chronic

Chronic Disease
Arteriosclerosis
Kidney Diseases
Rosiglitazone
Inflammation

Additional relevant MeSH terms:

Disease Attributes
Hypoglycemic Agents
Pathologic Processes

Physiological Effects of Drugs
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009